A Dose-Finding Study of Vedolizumab for Treatment of Ster... | NCT02993783

ID	Type	Description	Link
2016-002985-30	EudraCT Number
U1111-1185-6832	Other Identifier	WHO

Label	Type	Description	Intervention Names
Vedolizumab 300 mg	Experimental	Vedolizumab 300 mg, intravenous (IV) infusion, once on Days 1, 15, 43, 71 and 99.	Drug: Vedolizumab
Vedolizumab 600 mg	Experimental	Vedolizumab 600 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.	Drug: Vedolizumab

Name	Type	Description	Arm Group Labels	Other Names
Vedolizumab	Drug	Vedolizumab IV infusion	Vedolizumab 300 mg Vedolizumab 600 mg

Measure	Description	Time Frame
Percentage of Participants With Overall Response (Partial Response [PR]+Very Good Partial Response [VGPR]+Complete Response [CR]) at Day 28	CR is defined as the resolution of all signs and symptoms of acute graft-versus-host-disease (GvHD). VGPR is defined as resolution of the signs and symptoms of the GvHD: 1) Skin: no rash, or residual erythematous rash involving <25% of the body surface, without bullae (excluding residual faint erythema and hyperpigmentation). 2) Liver: total serum bilirubin concentration <2 mg/dL or <25% of baseline at enrollment. 3) Gut: a) participant tolerates food or enteral feeding; b) predominantly formed stools; c) no overt gastrointestinal bleeding or abdominal cramping; d) no more than occasional nausea or vomiting. PR is defined as improvement of 1 GvHD stage in 1 or more organs without progression in any organ.	Day 28
Number of Participants Who Experienced Serious Adverse Events (SAEs) Through Day 28	An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An SAE is defined as an untoward medical occurrence, significant hazard, contraindication, side effect or precaution that at any dose: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.	From first dose up to Day 28

Measure	Description	Time Frame
Percentage of Participants Who Died in the Absence of Primary Malignancy Relapse After Allo-HSCT at Month 6		Month 6
Percentage of Participants With Acute GvHD Complete Response (CR) at Day 28	CR is defined as the resolution of all signs and symptoms of acute GvHD.

Name	Affiliation	Role
Study Director	Millennium Pharmaceuticals, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Massachusetts General Hospital		Boston	Massachusetts	02114	United States
Washington University

PubMed Identifier	Type	Citation	Retractions
34108672	Derived	Floisand Y, Schroeder MA, Chevallier P, Selleslag D, Devine S, Renteria AS, Mohty M, Yakoub-Agha I, Chen C, Parfionovas A, Quadri S, Jansson J, Akbari M, Chen YB. A phase 2a randomized clinical trial of intravenous vedolizumab for the treatment of steroid-refractory intestinal acute graft-versus-host disease. Bone Marrow Transplant. 2021 Oct;56(10):2477-2488. doi: 10.1038/s41409-021-01356-0. Epub 2021 Jun 9.

ID	Title	Description
FG000	Vedolizumab 300 mg	Vedolizumab 300 mg, intravenous (IV) infusion, once on Days 1, 15, 43, 71 and 99.
FG001	Vedolizumab 600 mg	Vedolizumab 600 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
SAP	No	Yes	No	Statistical Analysis Plan	Sep 13, 2018	May 1, 2019

ID	Title	Description
BG000	Vedolizumab 300 mg	Vedolizumab 300 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.
BG001	Vedolizumab 600 mg	Vedolizumab 600 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG0008 BG0019 BG00217

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants With Overall Response (Partial Response [PR]+Very Good Partial Response [VGPR]+Complete Response [CR]) at Day 28

CR is defined as the resolution of all signs and symptoms of acute graft-versus-host-disease (GvHD). VGPR is defined as resolution of the signs and symptoms of the GvHD: 1) Skin: no rash, or residual erythematous rash involving <25% of the body surface, without bullae (excluding residual faint erythema and hyperpigmentation). 2) Liver: total serum bilirubin concentration <2 mg/dL or <25% of baseline at enrollment. 3) Gut: a) participant tolerates food or enteral feeding; b) predominantly formed stools; c) no overt gastrointestinal bleeding or abdominal cramping; d) no more than occasional nausea or vomiting. PR is defined as improvement of 1 GvHD stage in 1 or more organs without progression in any organ.

Efficacy analysis set included all participants from the safety set who had baseline efficacy assessment and at least one post-baseline efficacy assessment.

Posted

Number

95% Confidence Interval

percentage of participants

Day 28

ID	Title	Description
OG000	Vedolizumab 300 mg	Vedolizumab 300 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.
OG001	Vedolizumab 600 mg	Vedolizumab 600 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.

Units	Counts
Participants	OG0008 OG0019

Title

Denominators

Categories

Title	Measurements
	OG00050.0(15.7 to 84.3) OG00122.2(2.8 to 60.0)

Primary

Number of Participants Who Experienced Serious Adverse Events (SAEs) Through Day 28

An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An SAE is defined as an untoward medical occurrence, significant hazard, contraindication, side effect or precaution that at any dose: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.

SAS included all participants who received any amount of the study drug.

Posted

Count of Participants

Participants

From first dose up to Day 28

ID	Title	Description
OG000	Vedolizumab 300 mg	Vedolizumab 300 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.
OG001	Vedolizumab 600 mg	Vedolizumab 600 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.

Units	Counts
Participants

Secondary

Percentage of Participants Who Died in the Absence of Primary Malignancy Relapse After Allo-HSCT at Month 6

Efficacy analysis set included all participants from the safety set who had baseline efficacy assessment and at least one post-baseline efficacy assessment.

Posted

Number

95% Confidence Interval

percentage of participants

Month 6

ID	Title	Description
OG000	Vedolizumab 300 mg	Vedolizumab 300 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.
OG001	Vedolizumab 600 mg	Vedolizumab 600 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Acute GvHD Complete Response (CR) at Day 28

CR is defined as the resolution of all signs and symptoms of acute GvHD.

Efficacy analysis set included all participants from the safety set who had baseline efficacy assessment and at least one post-baseline efficacy assessment.

Posted

Number

95% Confidence Interval

percentage of participants

Day 28

ID	Title	Description
OG000	Vedolizumab 300 mg	Vedolizumab 300 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.
OG001	Vedolizumab 600 mg	Vedolizumab 600 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Intestinal Overall Response at Day 28

Symptoms of acute intestinal GvHD were measured using the BMT CTN-modified International Bone Marrow Transplant Registry Database (IBMTR) index. Intestinal overall response is either CR, VGPR or PR for intestine only. CR is defined as the resolution of all signs and symptoms of GvHD. VGPR is defined as resolution of the majority of signs and symptoms of intestinal GvHD: a) participant tolerates food or enteral feeding; b) predominantly formed stools; c) no overt gastrointestinal bleeding or abdominal cramping; d) no more than occasional nausea or vomiting. PR is defined as improvement of intestinal GvHD by at least 1 stage.

Efficacy analysis set included all participants from the safety set who had baseline efficacy assessment and at least one post-baseline efficacy assessment.

Posted

Number

95% Confidence Interval

percentage of participants

Day 28

ID	Title	Description
OG000	Vedolizumab 300 mg	Vedolizumab 300 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.
OG001	Vedolizumab 600 mg	Vedolizumab 600 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.

Units	Counts

Secondary

Kaplan-Meier Estimate of Percentage of Participants Achieving Survival at Months 6 and 12

The Kaplan-Meier estimate reports the percentage of participants surviving at Months 6 and 12.

Efficacy analysis set included all participants from the safety set who had baseline efficacy assessment and at least one post-baseline efficacy assessment.

Posted

Number

95% Confidence Interval

percentage of participants

Months 6 and 12

ID	Title	Description
OG000	Vedolizumab 300 mg	Vedolizumab 300 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.
OG001	Vedolizumab 600 mg	Vedolizumab 600 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants Alive Without GvHD or Primary Malignancy Relapse at Months 6 and 12

Efficacy analysis set included all participants from the safety set who had baseline efficacy assessment and at least one post-baseline efficacy assessment.

Posted

Number

percentage of participants

Months 6 and 12

ID	Title	Description
OG000	Vedolizumab 300 mg	Vedolizumab 300 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.
OG001	Vedolizumab 600 mg	Vedolizumab 600 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.

Units	Counts
Participants	OG000

Secondary

Total Dose of Steroids Administered

Total Steroids administered in mg/kg/day of methylprednisolone or equivalent

Efficacy analysis set included all participants from the safety set who had baseline efficacy assessment and at least one post-baseline efficacy assessment.

Posted

Mean

Standard Deviation

mg/kg/day

From first dose of study drug up to Months 6 and 12

ID	Title	Description
OG000	Vedolizumab 300 mg	Vedolizumab 300 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.
OG001	Vedolizumab 600 mg	Vedolizumab 600 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.

Units	Counts
Participants	OG000

Secondary

Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs)

An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.

SAS included all participants who received any amount of the study drug.

Posted

Count of Participants

Participants

From first dose of study drug to 18 weeks after last dose (Up to Week 32)

ID	Title	Description
OG000	Vedolizumab 300 mg	Vedolizumab 300 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.
OG001	Vedolizumab 600 mg	Vedolizumab 600 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.

Units	Counts
Participants

Secondary

Number of Participants Who Experienced Serious Adverse Events (SAEs) Through Week 32

An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An SAE is defined as an untoward medical occurrence, significant hazard, contraindication, side effect or precaution that at any dose: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.

SAS included all participants who received any amount of the study drug.

Posted

Count of Participants

Participants

From first dose of study drug to 18 weeks after last dose (Up to Week 32)

ID	Title	Description
OG000	Vedolizumab 300 mg	Vedolizumab 300 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.
OG001	Vedolizumab 600 mg	Vedolizumab 600 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.

Units	Counts
Participants

Secondary

Number of Participants With Markedly Abnormal Laboratory Parameters Values

Clinical Laboratory parameters included tests for chemistry, hematology and urinalysis. Markedly abnormal values during treatment period were categorized as:alanine aminotransferase (ALT)>3.0 U/L*upper limit of normal(ULN),albumin<25 g/L*lower limit of normal(LLN),alkaline phosphatase >3.0 U/L*ULN,aspartate aminotransferase >3.0 U/L*ULN,bilirubin >2 umol/L*ULN,blood urea nitrogen(BUN) >10.7 mmol/L,calcium <1.75 mmol/L, >2.88 mmol/L,chloride <75 mmol/L, >126 mmol/L,creatinine >177umol/L,gamma glutamyl transferase (GGT) >3 U/L*ULN,glucose <2.8 mmol/L, >19.4 mmol/L,phosphate <0.52 mmol/L, >2.10 mmol/L,potassium<3 mmol/L, >6 mmol/L,sodium <130 mmol/L, >150 mmol/L,basophils >3(10^9/L)*ULN,eosinophils >2(10^9/L)*ULN,hematocrit (%) <0.8*LLN, >1.2*ULN,hemoglobin <0.8 g/L*LLN, >1.2 g/L*ULN,leukocytes <0.5 (10^9/L)*LLN, >1.5 (10^9/L)*ULN,lymphocytes <0.5 (10^9/L)*LLN, >1.5(10^9/L)*ULN,monocytes >2 (10^9/L)*ULN,neutrophils <0.5(10^9/L)*LLN, >1.5 (10^9/L)*ULN,platelets <75(10^9/L), >600(10^9/L).

SAS included all participants who received any amount of the study drug.

Posted

Count of Participants

Participants

From Baseline up to last dose of study drug (Day 99)

ID	Title	Description
OG000	Vedolizumab 300 mg	Vedolizumab 300 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.
OG001	Vedolizumab 600 mg

Secondary

Number of Participants With Markedly Abnormal Vital Signs

Vital signs included heart rate, respiratory rate, systolic and diastolic blood pressure, temperature and weight. The vital sign values outside the range: systolic blood pressure (SBP) <85 mmHg and change from Baseline (BL) <=-20 mmHg, >180 mmHg and change from Baseline >=20 mmHg,diastolic blood pressure (DBP) <50 mmHg and change from Baseline <=-15 mmHg, >110 mmHg and change from Baseline >=15 mmHg, heart rate <50 beats per minute (bpm),>120 beats per minute, temperature <35.6 Degree C, >37.7 Degree C and weight change from Baseline <=-7 % and weight change from Baseline >=7 % assessed during treatment period were considered markedly abnormal.

SAS included all participants who received any amount of the study drug.

Posted

Count of Participants

Participants

From Baseline up to last dose of study drug (Day 99)

ID	Title	Description
OG000	Vedolizumab 300 mg	Vedolizumab 300 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.
OG001	Vedolizumab 600 mg	Vedolizumab 600 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.

Units	Counts

Secondary

Ctrough: Trough Serum Concentrations of Vedolizumab

Pharmacokinetic (PK) set included all participants from the safety set with at least 1 post dose PK sample collected.

Posted

Mean

Standard Deviation

ug/mL

Day 99 (pre-dose)

ID	Title	Description
OG000	Vedolizumab 300 mg	Vedolizumab 300 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.
OG001	Vedolizumab 600 mg	Vedolizumab 600 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Thrombotic microangiopathy	Blood and lymphatic system disorders	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0011 affected9 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Death	General disorders	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk
Graft versus host disease	Immune system disorders	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0013 affected9 at risk
Acute graft versus host disease	Immune system disorders	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Acute graft versus host disease in intestine	Immune system disorders	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk
Acute graft versus host disease in liver	Immune system disorders	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Graft versus host disease in gastrointestinal tract	Immune system disorders	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Peritonitis	Infections and infestations	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Bacterial sepsis	Infections and infestations	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk
Citrobacter sepsis	Infections and infestations	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Cytomegalovirus colitis	Infections and infestations	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Enterococcal sepsis	Infections and infestations	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0011 affected9 at risk
Escherichia infection	Infections and infestations	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Mediastinitis	Infections and infestations	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Pneumonia necrotising	Infections and infestations	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk
Sepsis	Infections and infestations	MedDRA version 21.0	Systematic Assessment	EG0002 affected8 at risk EG0011 affected9 at risk
Urosepsis	Infections and infestations	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk
Post procedural complication	Injury, poisoning and procedural complications	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Tremor	Nervous system disorders	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Swelling face	Skin and subcutaneous tissue disorders	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Haematoma	Vascular disorders	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Hypotension	Vascular disorders	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA version 21.0	Systematic Assessment	EG0004 affected8 at risk EG0013 affected9 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0013 affected9 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA version 21.0	Systematic Assessment	EG0002 affected8 at risk EG0011 affected9 at risk
Aplasia pure red cell	Blood and lymphatic system disorders	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Pericardial effusion	Cardiac disorders	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk
Sinus bradycardia	Cardiac disorders	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Adrenal insufficiency	Endocrine disorders	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Vision blurred	Eye disorders	MedDRA version 21.0	Systematic Assessment	EG0002 affected8 at risk EG0010 affected9 at risk
Dry eye	Eye disorders	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Eye pruritus	Eye disorders	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Lacrimation increased	Eye disorders	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0012 affected9 at risk
Nausea	Gastrointestinal disorders	MedDRA version 21.0	Systematic Assessment	EG0003 affected8 at risk EG0010 affected9 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0011 affected9 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0012 affected9 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0011 affected9 at risk
Vomiting	Gastrointestinal disorders	MedDRA version 21.0	Systematic Assessment	EG0002 affected8 at risk EG0010 affected9 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Ascites	Gastrointestinal disorders	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk
Constipation	Gastrointestinal disorders	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk
Dry mouth	Gastrointestinal disorders	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Gingival pain	Gastrointestinal disorders	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk
Ileus paralytic	Gastrointestinal disorders	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk
Oral mucosa haematoma	Gastrointestinal disorders	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk
Proctalgia	Gastrointestinal disorders	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Stomatitis	Gastrointestinal disorders	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk
Tongue discolouration	Gastrointestinal disorders	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Oedema peripheral	General disorders	MedDRA version 21.0	Systematic Assessment	EG0003 affected8 at risk EG0013 affected9 at risk
Fatigue	General disorders	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0013 affected9 at risk
Pyrexia	General disorders	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0012 affected9 at risk
Generalised oedema	General disorders	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0011 affected9 at risk
Asthenia	General disorders	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk
Catheter site haemorrhage	General disorders	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Chills	General disorders	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk
Injection site pain	General disorders	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk
Oedema	General disorders	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk
Pain	General disorders	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk
Hypogammaglobulinaemia	Immune system disorders	MedDRA version 21.0	Systematic Assessment	EG0002 affected8 at risk EG0011 affected9 at risk
Graft versus host disease in gastrointestinal tract	Immune system disorders	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0012 affected9 at risk
Graft versus host disease in skin	Immune system disorders	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0011 affected9 at risk
Acute graft versus host disease in intestine	Immune system disorders	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk
Acute graft versus host disease in skin	Immune system disorders	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk
Cytomegalovirus infection	Infections and infestations	MedDRA version 21.0	Systematic Assessment	EG0002 affected8 at risk EG0011 affected9 at risk
BK virus infection	Infections and infestations	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0011 affected9 at risk
Enterococcal infection	Infections and infestations	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0011 affected9 at risk
Klebsiella infection	Infections and infestations	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0011 affected9 at risk
Staphylococcal infection	Infections and infestations	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0012 affected9 at risk
Urinary tract infection enterococcal	Infections and infestations	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0011 affected9 at risk
Aspergillus infection	Infections and infestations	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Clostridial infection	Infections and infestations	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk
Clostridium difficile infection	Infections and infestations	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk
Corona virus infection	Infections and infestations	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk
Cytomegalovirus colitis	Infections and infestations	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk
Device related infection	Infections and infestations	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Enterobacter infection	Infections and infestations	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk
Escherichia infection	Infections and infestations	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk
Infection	Infections and infestations	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Mastoiditis	Infections and infestations	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Otitis externa	Infections and infestations	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk
Pneumonia	Infections and infestations	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Pseudomonas infection	Infections and infestations	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Septic shock	Infections and infestations	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Sinusitis	Infections and infestations	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk
Urinary tract infection	Infections and infestations	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Urinary tract infection bacterial	Infections and infestations	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk
Urosepsis	Infections and infestations	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk
Vaginal infection	Infections and infestations	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk
Fall	Injury, poisoning and procedural complications	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk
Blood bilirubin increased	Investigations	MedDRA version 21.0	Systematic Assessment	EG0002 affected8 at risk EG0012 affected9 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0012 affected9 at risk
Platelet count decreased	Investigations	MedDRA version 21.0	Systematic Assessment	EG0002 affected8 at risk EG0011 affected9 at risk
White blood cell count decreased	Investigations	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0012 affected9 at risk
Alanine aminotransferase increased	Investigations	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0011 affected9 at risk
Aspartate aminotransferase increased	Investigations	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0011 affected9 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0011 affected9 at risk
Blood urea increased	Investigations	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0012 affected9 at risk
BK polyomavirus test positive	Investigations	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Blood beta-D-glucan increased	Investigations	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Blood creatine increased	Investigations	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Blood pressure decreased	Investigations	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Cytomegalovirus test positive	Investigations	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Electrocardiogram QT prolonged	Investigations	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Liver function test abnormal	Investigations	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk
Neutrophil count decreased	Investigations	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Oxygen saturation decreased	Investigations	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Urine output decreased	Investigations	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Vitamin D decreased	Investigations	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Weight decreased	Investigations	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA version 21.0	Systematic Assessment	EG0003 affected8 at risk EG0015 affected9 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA version 21.0	Systematic Assessment	EG0003 affected8 at risk EG0012 affected9 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA version 21.0	Systematic Assessment	EG0002 affected8 at risk EG0013 affected9 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0013 affected9 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0012 affected9 at risk
Hypermagnesaemia	Metabolism and nutrition disorders	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0012 affected9 at risk
Acidosis	Metabolism and nutrition disorders	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Fluid imbalance	Metabolism and nutrition disorders	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Hypernatraemia	Metabolism and nutrition disorders	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA version 21.0	Systematic Assessment	EG0002 affected8 at risk EG0012 affected9 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0011 affected9 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk
Anogenital warts	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Dizziness	Nervous system disorders	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0013 affected9 at risk
Headache	Nervous system disorders	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0011 affected9 at risk
Somnolence	Nervous system disorders	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0012 affected9 at risk
Ageusia	Nervous system disorders	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Clonus	Nervous system disorders	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Embolic stroke	Nervous system disorders	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Head titubation	Nervous system disorders	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk
Paraesthesia	Nervous system disorders	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk
Presyncope	Nervous system disorders	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Tremor	Nervous system disorders	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk
Depression	Psychiatric disorders	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0011 affected9 at risk
Anxiety	Psychiatric disorders	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk
Insomnia	Psychiatric disorders	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0011 affected9 at risk
Pollakiuria	Renal and urinary disorders	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Proteinuria	Renal and urinary disorders	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Urinary retention	Renal and urinary disorders	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Oedema genital	Reproductive system and breast disorders	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0012 affected9 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0011 affected9 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0012 affected9 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0011 affected9 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0011 affected9 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0011 affected9 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA version 21.0	Systematic Assessment	EG0002 affected8 at risk EG0010 affected9 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Increased bronchial secretion	Respiratory, thoracic and mediastinal disorders	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Upper-airway cough syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Pain of skin	Skin and subcutaneous tissue disorders	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0011 affected9 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk
Blister	Skin and subcutaneous tissue disorders	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Ingrowing nail	Skin and subcutaneous tissue disorders	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk
Lichen planus	Skin and subcutaneous tissue disorders	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk
Onychoclasis	Skin and subcutaneous tissue disorders	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Rash macular	Skin and subcutaneous tissue disorders	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Hypotension	Vascular disorders	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0012 affected9 at risk
Haematoma	Vascular disorders	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Hypertension	Vascular disorders	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Jugular vein thrombosis	Vascular disorders	MedDRA version 21.0	Systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk
Venoocclusive disease	Vascular disorders	MedDRA version 21.0	Systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk
Haematuria	Renal and urinary disorders	MedDRA version 21.0	Systematic Assessment	EG0002 affected8 at risk EG0010 affected9 at risk

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Vedolizumab 300 mg	Vedolizumab 300 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.	4	8	6	8	8	8
EG001	Vedolizumab 600 mg	Vedolizumab 600 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.	9	9	9	9	9	9